{"id":4360,"date":"2022-03-14T07:48:06","date_gmt":"2022-03-14T11:48:06","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/irb\/?page_id=4360"},"modified":"2022-09-14T10:45:41","modified_gmt":"2022-09-14T14:45:41","slug":"part-11-compliance","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/irb\/submission-requirements\/special-submission-requirements\/part-11-compliance\/","title":{"rendered":"Part 11 Compliance"},"content":{"rendered":"<p>If you are investigating a drug or device and are utilizing an electronic system to maintain your study records and\/or use electronic signatures, your system must be compliant with Part 11 requirements.<\/p>\n<p><strong>Part 11 requirements<\/strong><\/p>\n<p>Boston University\u2019s (BU\u2019s) instance of REDCap is now available to use for FDA-regulated drug or device studies. If you are conducting a drug or device study and plan to use BU REDCap for any data collection, including e-consent, you must comply with\u00a0<a href=\"https:\/\/www.fda.gov\/media\/75414\/download\">FDA 21 CFR Part 11 requirements for electronic records and signatures<\/a>.\u00a0Please see guidance on this process here:<\/p>\n<p><a href=\"https:\/\/www.bu.edu\/researchsupport\/forms-policies\/redcap-research-electronic-data-capture-part-11-process-training\/\"><strong>REDCap (Research Electronic Data Capture) Part 11 Process &amp; Training<\/strong><\/a><\/p>\n<p>To get started, complete the\u00a0<a href=\"https:\/\/redcap.bumc.bu.edu\/surveys\/?s=NNTRLW8JF7DKM9TC\">BU REDCap Part 11 Request Form<\/a>. For information regarding BU REDCap user access and support, please email REDCap support at\u00a0<a href=\"mailto:rchelp@bu.edu\">rchelp@bu.edu<\/a>.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>If you are investigating a drug or device and are utilizing an electronic system to maintain your study records and\/or use electronic signatures, your system must be compliant with Part 11 requirements. Part 11 requirements Boston University\u2019s (BU\u2019s) instance of REDCap is now available to use for FDA-regulated drug or device studies. If you are [&hellip;]<\/p>\n","protected":false},"author":874,"featured_media":0,"parent":2625,"menu_order":16,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/4360"}],"collection":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/users\/874"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/comments?post=4360"}],"version-history":[{"count":4,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/4360\/revisions"}],"predecessor-version":[{"id":4434,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/4360\/revisions\/4434"}],"up":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2625"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/media?parent=4360"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}